Regulatory Analyst, Human Research Protection

UT Southwestern Medical Center • Dallas, TX

9d

About The Position

The Regulatory Analyst works closely with investigators and research personnel to develop and refine proposals for human clinical trials or animal research. For campus-wide research, the role conducts thorough protocol pre-review before submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provides Principal Investigators with technical consultation on regulatory, scientific, and policy issues that may affect the likelihood of approval. The position collaborates with institutional regulatory entities and supports research program operations, quality control, internal controls, and compliance with applicable laws, regulations, policies, and procedures.

Requirements

• Bachelor's degree in a related field and 3 years of related experience, or a master's degree in a related field and 1 year of related experience.

Nice To Haves

• Advanced science degree.
• Extensive current knowledge of regulations governing human or animal research protections.
• Previous service on an IRB or IACUC.

Responsibilities

• Pre-review campus-wide research protocols before submission to the IRB or IACUC and advise Principal Investigators on regulatory, scientific, and policy issues affecting the likelihood of approval.
• Collaborate with the IRB or IACUC and other institutional regulatory entities to provide protocol review services for investigators.
• Direct, analyze, coordinate, and evaluate research program operations and procedures.
• Develop, cultivate, and maintain working relationships with internal and external departments, agencies, and organizations associated with or benefiting from the research program.
• Establish research program goals and objectives; direct clinical trials program evaluation and quality-control activities; and develop or approve schedules, priorities, and standards for achieving goals.
• Recommend new policies and procedures to improve program activities.
• Design, execute, and ensure the effectiveness of internal controls that provide reasonable assurance that operations are effective and efficient.
• Ensure compliance with applicable laws, regulations, policies, and procedures.
• Read relevant literature and attend training and other functions to stay current on scientific, regulatory, and technical developments related to research oversight.
• Perform other duties as assigned.

Benefits

• PPO medical plan available on day one at no cost for full-time employee-only coverage.
• 100% coverage for preventive healthcare with no copay.
• Paid time off available on day one.
• Retirement programs through the Teacher Retirement System of Texas (TRS).
• Paid parental leave benefit.
• Wellness programs.
• Tuition reimbursement.
• Public Service Loan Forgiveness (PSLF) qualified employer.
• On-site childcare.
• Paid holidays.
• Merit increases.

What This Job Offers

• Job Type: Full-time